Medical Device Training in Malaysia – HRD Corp Claimable Course

Labelling of Medical Devices (ISO 15223-1:2016) & Medical Device Classification


Medical devices open the possibilities for a multitude of medical procedures from a non-invasive sprained elbow bandaging, in-vitro fertilisation to an invasive robot assisted total knee replacement. It has been conservatively estimated by global health regulators that there are over 2 million different medical devices on the market categorised into thousands of generic device group-family. Hence for medical device industry personnel, the correct and regulation guided identification and classification are essential ‘must-know’ knowledge as current technology creates a myriad combination of presentation incorporating software, biologics, drugs or pure mechanical products.


Medical device classification within a risk-based system is essential to assist the manufacturer to position its medical device to an appropriate risk class within a regulator’s domain and more importantly to permit appropriate regulatory controls and resources to be allocated to a medical device proportionate to its risk level. When this is correctly performed it facilitates awareness for the medical device personnel to initiate a commmensurating level of risk counter measures to be in taken as far as possible for the product.


The primary purpose of labelling is to communicate the device safety, performance, device correct use information to the users as well as to permit identification of the individual devices. As these may be presented either on the device itself, on packaging, or as instructions for use, it must be capable to transfer the pertinent information as required by the regulators to ensure patient safety, product integrity in performance and its traceability. With the multitude of industry standardised signs and symbols available encompassing mechanical, electrical, biologics and pharmacological; medical device personnel must be able to navigate and translate the appropriate hieroglyphics to use, its intention and meaning appropriate for their product to reflect current ‘state of the art’.




To provide participants with the necessary competence and knowledge on what is a medical device as defined by regulators and the standards, classify the device according to the correct category as stipulated by the appropriate jurisdiction of enforcement and be able to recognise, interpret and or  apply the correct mandatory information and symbols onto a product label.

  • Understand the definition of a medical device and it varied forms as defined by the ISO standard and the US and EU regulators regulations and codes.
  • Be knowledgeable on the medical device risk base category classification technique.
  • Ability to recognise, translate and understand the appropriate mandatory and optional symbols and information to be presented on a product, it packaging and its IFU.



  • Detailed explanation on the definition of a medical device (ISO 13485, EU MDR 2017/ 745 and FDA FD&C Act) and its varied permissible forms i.e., software and combination devices;
  • Medical device classification in three recognised risk-based approach;
    • IMDRF (Class A, B, C and D)
    • FDA Food, Drug and Cosmetic Act (Class I, II and III)
    • EU Medical Device Regulation (Class I, I(s), IIa, IIb and III)
  • Exposure, explanation and practical application of;
    • ISO 15223-1: 2021 Symbols to be used with information to be supplied by the manufacturer
    • ISO 20417: 2021 Information to be supplied by the manufacturer
    • IEC TR 60878: 2022 Graphical symbols for electrical equipment in medical practices (overview)



At the end of the session, participants will:

  • Gain an understanding on what is defined as a medical device and differentiate what constitute a software as a medical device and a combination genre medical device.
  • Be knowledgeable and able to perform the classification of a medical device within the three globally recognised risk base approach.
  • Gain practical knowledge and skill from ISO 15223-1. ISO 20417 and IEC TR 60878 reflecting current ‘state of the art’.


This programme is designed for ALL functions and levels of an organization that need to gain knowledge and essential skills in this aspect of medical device product realisation.

This programme is particularly useful to those involve with the regulatory, quality, manufacturing and marketing of medical device product.

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